Z-1597-2020 Class II Ongoing

Recalled by Elekta Impac Software — Sunnyvale, CA

Recall Details

Product Type
Devices
Report Date
April 1, 2020
Initiation Date
September 24, 2019
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3732 units

Product Description

MOSAIQ, oncology information system - Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planning and delivery.

Reason for Recall

The user may inadvertently enter Metric values into Height and Weight fields labeled with US Standard Units.

Distribution Pattern

Worldwide distribution.

Code Information

Software Versions (UDI/GTIN): MOSAIQ 2.00 (00858164002305); MOSAIQ 2.20 (00858164002312); MOSAIQ 2.30 (00858164002329); MOSAIQ 2.40 (00858164002077); MOSAIQ 2.41 (00858164002084); MOSAIQ 2.60 -2.64 (00858164002091); MOSAIQ 2.50 (00858164002107); MOSAIQ 2.65 (00858164002220); MOSAIQ 2.70 (00858164002037); MOSAIQ 2.80 (00858164002251); MOSAIQ 2.81 (00858164002282)